Ability of nafamostat mesilate to prolong filter patency during continuous renal replacement therapy in patients at high risk of bleeding: a randomized controlled study

Yong Kyu Lee, Hae Won Lee, Kyu Hun Choi, Beom Seok Kim, Yong Kyu Lee, Hae Won Lee, Kyu Hun Choi, Beom Seok Kim

Abstract

Continuous renal replacement therapy (CRRT) is considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care units (ICUs). However, the role of heparin anticoagulation, which is used to maintain circuit patency, is equivocal due to the risk of bleeding and morbidity. Among various alternative anticoagulants, nafamostat mesilate has been shown to be an effective anticoagulant in patients prone to bleeding. Hence, we conducted a prospective, randomized controlled study investigating the effect of nafamostat mesilate on mortality, CRRT filter life span and adverse events in patients with bleeding tendency. Seventy-three Patients were randomized into either the futhan or no-anticoagulation group. Thirty-six subjects in the futhan group received nafamostat mesilate, while thirty seven subjects in the no-anticoagulation group received no anticoagulants. Baseline characteristics and appropriate laboratory tests were taken from each group. The mortality between the two groups was not significantly different. Nevertheless, between the futhan group and the no-anticoagulation group, the overall number of filters used during CRRT (2.71 ± 2.12 vs. 4.50 ± 3.25; p = 0.042) and the number of filters changed due to clots per 24 hours (1.15 ± 0.81 vs. 1.74 ± 1.62; p = 0.040) were significantly different. When filter life span was subdivided into below and over 12 hours, the number of filters functioning over 12 hours was significantly higher in the futhan group than in the no-anticoagulation group (p = 0.037, odds ratio 1.84). There were no significant differences in transfusion, mortality, or survival between the two groups, and no adverse events related to nafamostat mesilate were noted. Hence, nafamostat mesilate may be used as an effective and safe anticoagulant, without increasing the risk of major bleeding complications, in patients prone to bleeding.

Trial registration: Clinicaltrials.gov NCT01761994.

Conflict of interest statement

Competing Interests: This study was funded by SK chemical and Yonsei University College of Medicine. However this does not alter the authors' adherence to PLOS one policies on sharing data and materials.

Figures

Figure 1. Enrollment, randomization, and follow up.
Figure 1. Enrollment, randomization, and follow up.
Out of 162 patients who were eligible to the study, 73 patients were enrolled in the study, and 60 patients completed the study for analysis.
Figure 2. Survival curve of the Futhan…
Figure 2. Survival curve of the Futhan group and No-anticoagulation group.

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Source: PubMed

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